greenlight.guru Medical Device Blog

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Top 10 Most Popular Medical Device Articles of 2016 from greenlight.guru (Plus Top 5 Free Webinars and Podcasts) - Featured Image

Top 10 Most Popular Medical Device Articles of 2016 from greenlight.guru (Plus Top 5 Free Webinars and Podcasts)

Thanks for helping make 2016 another big and exciting year for greenlight.guru filled with growth! W...
The Business Case for Integrated Design Controls - Featured Image

The Business Case for Integrated Design Controls

What role do you believe design controls play in the growth and stability of your company? I suspect...
How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources - Featured Image

How a New Breed of Medical Device Companies Is Leveraging Technology to Get More Done with Less Resources

Zebra Medical Technologies is part of a new breed of medical device companies. They understand the r...
Medical Device Risk – ISO 14971 Gets It Right - Featured Image

Medical Device Risk – ISO 14971 Gets It Right

Editor's note: This is a guest post authored by William Storage, VP LiveSky Inc., Visiting Scholar, ...
Understanding the New FDA Guidance on Changes to a 510(k) - Featured Image

Understanding the New FDA Guidance on Changes to a 510(k)

What happens you need to make a change to a device that’s been cleared via 510(k)?
Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations - Featured Image

Preparing for the Changes to the EU Medical Device and In-Virto Diagnostics Regulations

Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Di...
ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes - Featured Image

ISO 13485:2016 vs. ISO 13485:2003 vs. FDA 21 CFR Part 820: Comparing the Differences and Changes

The publication and release of ISO 13485:2016 earlier this year is a significant movement for the me...
Tips for Avoiding Problems with the First-In-Human Study Process - Featured Image

Tips for Avoiding Problems with the First-In-Human Study Process

When it comes to moving from the conceptual phase of developing a medical device and actually doing ...
What's with the Rush to First-In-Human Studies? - Featured Image

What's with the Rush to First-In-Human Studies?

Any medical device initially starts with an idea — a problem to solve, with the hope of positively i...
How to Properly Use the FDA Pre-Submission Process and Why It's So Important - Featured Image

How to Properly Use the FDA Pre-Submission Process and Why It's So Important

In order to get your medical device to market, you will need to know about pre-submissions and the p...
How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time - Featured Image

How To Avoid Being Part of the 69% of 510(k) Submissions That Get Rejected the First Time

Did you know that 69% of 510(k) submissions were rejected the first time between January and June of...
Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer - Featured Image

Insider Tips and Best Practices Regarding the 510(k) Submission Process with Allison Komiyama, a Former FDA Reviewer

One important piece of documentation that medical device companies rely on to get them through the r...

The greenlight.guru Medical Device Blog

Providing you actionable tips, best practices and insights for better medical device quality, compliance and product development.